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Rac Leena Kadakia

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Rac Leena Kadakia

Vice President of Regulatory Affairs | RefleXion Medical

San Francisco, California, United States

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Rac Leena Kadakia

Summary

Leena Kadakia is a seasoned Vice President of Regulatory Affairs with extensive experience in the medical device industry, particularly in biomaterials and biomedical engineering. She has a proven track record of leading projects from concept to commercialization while ensuring compliance with international regulatory standards. With a Master's degree in Biomedical Engineering and a RAC certification, Leena is well-versed in FDA and EU regulatory requirements. Her expertise spans a variety of medical technologies, including electrophysiology and cardiovascular devices. Known for her strong organizational and communication skills, she excels in managing cross-functional teams and navigating complex regulatory landscapes. Leena's career reflects a deep commitment to advancing healthcare technologies through rigorous quality and regulatory practices. She has worked with both startups and established organizations, demonstrating versatility in her professional journey. Her passion for innovation is matched by her dedication to patient safety and product efficacy.

General

Specialist

Technical Background

Leadership Experience

Long-Term Tenure

Professional interests

Emerging Technologies

Leadership Development

Organisational experience

Corporate Experience

Consulting Experience

Rac Leena Kadakia

Work Experience

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Vice President of Regulatory Affairs at

RefleXion Medical

November 2022 - Present

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Director of Regulatory Affairs at

RefleXion Medical

January 2022 - October 2022

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Principal Regulatory Affairs Specialist at

RefleXion Medical

January 2020 - December 2021

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Consultant, Regulatory Affairs, Quality, and Engineering at

Multiple Companies

September 2013 - January 2020

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Consultant - Engineering/Design Controls at

Hansen Medical

December 2012 - December 2013

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Senior R&D Engineer at

Abbott Co

June 2012 - November 2012

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Catheter Engineer at

Hansen Medical

August 2008 - May 2012

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Product Development Engineer at

Resonetics (Previously Memry)

January 2007 - August 2008

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R&D Engineer at

Cordis

September 2005 - January 2007

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Process Dev. Engineer at

Lam Research

January 2000 - January 2003

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Rac Leena Kadakia

Education

UC Santa Cruz Extension, Certificate Program

January 2011 - January 2013

Johns Hopkins University, Ms

January 2003 - January 2005

Frequently Asked Questions about Rac Leena Kadakia

What is Rac Leena Kadakia email address?

Rac Leena Kadakia's primary email address is ********@reflexion.com. To view the full verified email and additional contact details, sign up for free with Muraena.

What company does Rac Leena Kadakia work for?

Rac Leena Kadakia is a Vice President of Regulatory Affairs at RefleXion Medical, a company specializing in Medical Equipment & Supplies Manufacturing.

Where Rac Leena Kadakia graduated from?

Rac Leena Kadakia holds a degree in Regulatory Affairs from UC Santa Cruz Extension.

How can I directly contact Rac Leena Kadakia?

To contact Rac Leena Kadakia directly, you can use the email address ********@reflexion.com. Complete contact information is available upon registration with Muraena.

Who is Rac Leena Kadakia?

Leena Kadakia is a seasoned Vice President of Regulatory Affairs with extensive experience in the medical device industry, particularly in biomaterials and biomedical engineering. She has a proven track record of leading projects from concept to commercialization while ensuring compliance with international regulatory standards. With a Master's degree in Biomedical Engineering and a RAC certification, Leena is well-versed in FDA and EU regulatory requirements. Her expertise spans a variety of medical technologies, including electrophysiology and cardiovascular devices. Known for her strong organizational and communication skills, she excels in managing cross-functional teams and navigating complex regulatory landscapes. Leena's career reflects a deep commitment to advancing healthcare technologies through rigorous quality and regulatory practices. She has worked with both startups and established organizations, demonstrating versatility in her professional journey. Her passion for innovation is matched by her dedication to patient safety and product efficacy.

Rac`s contact details

mail

********@reflexion.com

*****@alum.mit.edu

Colleagues

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Michael Benjamin

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Sean Shirvani Md Mph

Chief Medical Officer

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Judy Bartlett-Roberto

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Diana King

VP of Service & Support

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Jay Janardhanan

Vice President, Software Engineering

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Renee Ryan

EIR Expert

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Todd Powell

President & CEO

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